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Implementing Mindfulness Practice to Advance Sleep Health Equity Among Black Women
The purpose of this study is to achieve health and healthcare equity by implementing an equity-focused, mindfulness-based sleep intervention to reduce stress and sleep deficiency-related cardiometabolic disease burden in Black women.
In phases 1 and 2, the investigator will identify multi-level barriers and facilitators to implementing the online mindfulness-based therapy for insomnia (MBTI) through an equity lens using community-engaged research with key stakeholders. The investigators will then develop and refine equity-focused implementation strategies with the community advisory board, comprised of community-based organization members, African Methodist Episcopal Zion Church networks, clinicians, and community health workers (CHWs). In phase 3, the investigators will use a Hybrid Type 1 effectiveness/implementation design with a pragmatic randomized controlled trial with MBTI and a waitlist control in Black women with insomnia. Specialists will assess and address social needs of Black women, and registered nurses will deliver the online MBTI intervention in the community settings. The focus of this registration is phase 3. The study will contribute to equity-focused implementation science and policy decisions by providing multi-level implementation determinants, equity-relevant metrics, and contextual factors through community-engaged research and evaluation of the outcomes.
Age
18 - 70 years
Sex
FEMALE
Healthy Volunteers
No
Yale School of Nursing
New Haven, Connecticut, United States
Yale School of Nursing Biobehavioral Lab
West Haven, Connecticut, United States
Start Date
January 6, 2026
Primary Completion Date
July 1, 2028
Completion Date
August 31, 2028
Last Updated
February 19, 2026
340
ESTIMATED participants
Mindfulness-based therapy for insomnia (MBTI)
BEHAVIORAL
Lead Sponsor
Yale University
Collaborators
NCT06032377
NCT06807086
NCT06181643
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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